California Company Surprised After Getting Slammed By US FDA For Marketing Of Imaging Device
Executive Summary
Total Thermal Imaging, a company that promotes thermal imaging technology over mammography to detect breast cancer, says it is surprised the agency is coming after them for "illegally marketing" their test for unapproved indications. The company says it thought it had complied with all of FDA’s requirements but is willing to consider filing a 510(k) if needed.